Identification of Null Allelic Variant of CYP2C8 In A Kor... | NCT01872780

Studies
Identification of Null Allelic Variant of CYP2C8 In A Korean Population

NCT01872780

Sponsor

Inje University

Status

Completed

Last Update Posted

Jun 7, 2013Estimated

Enrollment

11Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Rosiglitazone
CYP2C8 genotype

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Feb 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Dec 6, 2011

First Submission Date that Met QC Criteria

Jun 5, 2013

First Posted Date

Jun 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2013

Last Update Posted Date

Jun 7, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jae-Gook Shin, Department of Pharmacology and Pharmacogenomics Research Center, Inje UniversityPrincipal Investigator

Lead Sponsor

Inje UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The genotype profile of CYP2C8 was analyzed in a Korean population. Frequency in multi-ethnic population and in vivo functionality of novel null allelic CYP2C8 variant were evaluated.

Detailed Description

Whole blood samples from 50 unrelated Korean subjects were genotyped for 3kb of 5' upstream region, all exon-intron boundaries, exons, and UTR regions of CYP2C8 gene by direct sequencing. Genotyping of CYP2C8 has been addressed only for null allelic variant, CYP2C8*11 using pyrosequencing in the 447 Koreans, 93 African-Americans, 100 Caucasians, 348 Chineses and 100 Vietnameses. Then, in-vivo single PK study of CYP2C8 probe, rosiglitazone(4mg), was conducted in 7 healthy subjects with CYP2C8*1/*1 and 2 with CY2C8*1/*11.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rosiglitazone	Active Comparator	avandia	Drug: Rosiglitazone Genetic: CYP2C8 genotype
genetic polymorphism	Active Comparator	avandia CYP2C8 genotype	Drug: Rosiglitazone Genetic: CYP2C8 genotype

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rosiglitazone	Drug	single oral administration of 4mg of rosiglitazone	genetic polymorphism rosiglitazone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC	0h,0.33h,0.66h,1h,1.5h,2h,3h,4h,6h,8h,12h,24h	12hr

Secondary Outcomes

Measure	Description	Time Frame
Cmax	0h,0.33h,0.66h,1h,1.5h,2h,3h,4h,6h,8h,12h,24h	12hr

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy volunteer

Exclusion Criteria:

Medical problems in taking probe drug

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jae-Gook Shin, MD, PhD	Inje University	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077154	Rosiglitazone

Ancestor Terms

ID	Term
D045162	Thiazolidinediones
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided